Drug companies urge appeals court to remove judge from U.S. opioid litigation

Eight drug companies on Tuesday urged a federal appeals court to disqualify the judge overseeing nationwide opioid litigation, in a last-ditch effort to avoid having him preside over a landmark trial in three weeks.

The request came six days after U.S. District Judge Dan Polster in Cleveland refused to recuse himself and said he had done nothing to favor the state and local governments suing for damages, including by encouraging settlements.
But the eight pharmacy chains and drug distributors told the 6th U.S. Circuit Court of Appeals in Cincinnati that Polster has “lost sight” of his responsibility to appear unbiased, including by acknowledging a “personal mission” to address the opioid crisis.
Polster oversees more than 2,300 of the roughly 2,600 lawsuits brought by state, local and tribal governments, hospitals and other entities seeking to hold the drug industry responsible for the toll of opioid abuse.
The scheduled Oct. 21 trial is the first in a federal court.

Ohio’s Cuyahoga and Summit counties, the only plaintiffs, want $8 billion of damages, according to the eight companies.
“The time for disqualification is now,” the companies said.
They added that removing Polster would help preserve “public confidence in the integrity of the judicial system. That should be a special imperative in this litigation, which is so much in the public eye.”
The companies include retailers CVS Health Corp, Rite Aid Corp, Walgreens Boots Alliance Inc and Walmart Inc, and distributors AmerisourceBergen Corp, Cardinal Health Inc, Henry Schein Inc and McKesson Corp.
Their disqualification request, originally made directly to Polster on Sept. 14, followed several rulings against them.
Legal experts have called the effort to remove Polster a long shot, saying it is common for judges to encourage settlements and that disqualifications are rare.
Ohio, 13 other states and Washington, D.C. have separately asked the appeals court to halt the upcoming trial, saying it undermines their right to litigate on their own.
Opioid addiction claimed roughly 400,000 lives in the United States from 1999 to 2017, according to the U.S. Centers for Disease Control and Prevention.
https://www.reuters.com/article/us-usa-opioids-litigation/drug-companies-urge-appeals-court-to-remove-judge-from-u-s-opioid-litigation-idUSKBN1WG4IP

Savara slides 50%-plus after FDA rejects Molgradex

Savara (NASDAQ:SVRA) -57.6% pre-market after the Food and Drug Administration said data on the development program for the company’s Molgradex lung disease treatment do not provide sufficient evidence of efficacy and safety.

SVRA says the FDA did not recommend submission of a Biologics License Application for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor.

The company says it remains “committed to the Molgradex development program and believe that it will provide aPAP patients with a meaningful treatment option.”

https://seekingalpha.com/news/3503310-savara-slides-50-percent-plus-fda-rejects-molgradex

PTC Therapeutics Risdiplam Spinal Muscular Atrophy Data Continues Benefit

PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced data demonstrating the ongoing benefit of risdiplam (RG7916) for the treatment of all types of spinal muscular atrophy (SMA) at the 24th International Annual Congress of the World Muscle Society. Presentations include data from the FIREFISH, SUNFISH, and JEWELFISH clinical trials. The SMA program is a collaboration between PTC, the SMA Foundation, and Roche.
“We are excited that risdiplam has the potential to enter the market with a best-in-class profile for patients with all types of SMA,” said Stuart W. Peltz, Ph.D., Chief Executive Officer of PTC Therapeutics. “These data continue to demonstrate the disease-modifying properties of risdiplam across a broad range of ages and infants receiving the drug are continuing to experience improved motor outcomes.  Importantly, these results help validate PTC’s splicing platform that is currently being used in other programs.”
Data from Part 1 of the FIREFISH clinical trial demonstrated that after 16 months of treatment, 82% (14/17) of high-dose patients had a CHOP-INTEND score ≥40. 86% (18/21) of all infants were event-free after receiving risdiplam for 16 months. No infant has required tracheostomy or reached permanent ventilation. The primary objective of FIREFISH Part 1 was to assess the safety profile of risdiplam in infants and determine the dose for Part 2.
In patients in Part 1 of the SUNFISH clinical trial, risdiplam treatment led to a median two-fold increase in blood SMN protein levels after four weeks of treatment, sustained for at least 12 months. In the natural history cohort, patients did not experience any change in SMN protein levels over the same period. Patients receiving risdiplam in SUNFISH Part 1 showed a clinically meaningful increase in total MFM32 score including a broad range of ages and functional status at baseline compared with natural history, independent of age and disease severity. SUNFISH Part 1 is focused on the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy in patients with type 2 or 3 SMA between 2 and 25 years old.
Data from 45 patients in the JEWELFISH trial demonstrated a sustained, greater than two-fold increase in median SMN protein versus baseline over 12 months of treatment. Patients in the JEWELFISH study have previously been treated with nusinersen or other therapies.

https://www.marketscreener.com/PTC-THERAPEUTICS-INC-13450034/news/PTC-Therapeutics-Risdiplam-Spinal-Muscular-Atrophy-Data-Demonstrating-Continued-Benefit-Presented-29325589/

Walgreens, Postmates To Collaborate on Delivery in Manhattan and Brooklyn

Walgreens Boots Alliance, Inc. (WBA) and Postmates said they would collaborate on delivery for customers.
With the collaboration, Postmates will deliver health and wellness, beauty and grocery products from 174 Walgreens and Duane Reade locations in Manhattan and Brooklyn.
“In the last year, orders from convenience and drugstores have increased by 68%. By collaborating with Walgreens, we are able to provide our customers with even more convenience when it comes to everyday items that they need now,” said Craig Whitmer, vice president of merchant business development for Postmates.
To order items from participating Walgreens stores, users can go to the Postmates website or download the Postmates app.
https://www.marketscreener.com/WALGREENS-BOOTS-ALLIANCE-19356230/news/Walgreens-Boots-Alliance-Postmates-To-Collaborate-on-Delivery-in-Manhattan-and-Brooklyn-29325737/

Wedbush: Investors Largely Underappreciating AnaptysBio

AnaptysBio Inc ANAB released topline results Monday from an interim data analysis from a midstage study of its investigational asset ANAB019, which being evaluated for moderate-to-severe generalized pustular psoriasis.

The Analyst

Wedbush analyst David Nierengarten reiterated an Outperform rating on AnaptysBio with a $146 price target

The Thesis

Overall, new data from the study showed highly compelling efficacy, with rapid and sustained reductions in relevant disease metrics from the initial day eight assessment to the day 113 assessment, Nierengarten said in a Tuesday note. 

Compared to Boehringer Ingelheim’s IL-36R inhibitor B1655130, the analyst said he sees the potential for NB019 to become the best-in-the-class antagonist.
With B1655130, anti-drug antibodies were observed in three patients, whichmay limit prolonged and multiple dosing, he said.
With ANB019, neither of the two patients in the study required rescue therapy during the treatment period, Nierengarten said; one patient treated with B1655130 required rescue therapy.
Despite the different efficacy scales used in the two studies that rendered the data incomparable, ANB019’s lack of observed anti-drug antibodies represents a key potential differentiator relative to B1655130, the analyst said.
AnaptysBio plans to continue enroll patients in the midstage study, with an enrollment target of 10 patients, he said.
The company is expected to give a data and development update for the program later in 2020, Nierengarten said.
The analyst sees the data as having a positive read-through to the Phase 2 POPLAR study that is evaluating ANB019 in an inflammatory skin condition, palmoplantar pustulosis.
“As such, with interim Ph 2 GPP data de-risking the asset and multiple data readouts for ANB019 expected over the next 12 months, we believe that investors are largely underappreciating ANAB’s second clinical candidate (and ANAB shares in general).”
The upcoming topline Phase 2b ATLAS study readout for AnaptysBio’s lead candidate etokimab in atopic dermatitis and the topline Phase 2 ECLIPSE readout in chronic rhinosinusitis with nasal polyps in the fourth quarter of 2019 could serve as the next major drivers of share value, according to Wedbush.
https://www.benzinga.com/analyst-ratings/analyst-color/19/10/14522016/wedbush-investors-largely-underappreciating-anaptysbio

ArQule launches registrational study of miransertib in PS and PROS

ArQule (NASDAQ:ARQL) doses first patient in the registrational MOSAIC (Miransertib in Overgrowth Syndromes in Adults and Children) trial of its oral, selective pan-AKT inhibitor, miransertib, for the treatment of Proteus syndrome (PS) and PIK3CA-related Overgrowth Spectrum disorders (PROS).

The study will enroll approx. 30-35 patients to evaluate the objective response to miransertib in patients with PS and PROS. Same number of patients will be enrolled in 2 other cohorts for patients under compassionate use or those ineligible to enter the registrational cohorts.

https://seekingalpha.com/news/3503283-arqule-launches-registrational-study-miransertib-ps-pros

Ra Pharmaceuticals launches late-stage zilucoplan trial for gMG

Ra Pharmaceuticals (NASDAQ:RARX) initiates dosing in the RAISE study, its pivotal, Phase 3 clinical trial evaluating zilucoplan for the treatment of generalized myasthenia gravis (gMG).

The trial is expected to enroll approx. 130 patients.

The primary endpoint is the change in the MG Activities of Daily Living (MG-ADL) score from baseline to week 12. Top-line results are expected in early 2021.

https://seekingalpha.com/news/3503286-ra-pharmaceuticals-launches-late-stage-zilucoplan-trial-gmg